The following data is part of a premarket notification filed by Ethicon, Llc with the FDA for Dermabond Prineo Skin Closure System.
| Device ID | K163645 |
| 510k Number | K163645 |
| Device Name: | DERMABOND PRINEO Skin Closure System |
| Classification | Cutaneous Tissue Adhesive With Mesh |
| Applicant | Ethicon, LLC Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Contact | Joice Pappan |
| Correspondent | Joice Pappan Ethicon, LLC Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Product Code | OMD |
| CFR Regulation Number | 878.4011 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-04-21 |
| Summary: | summary |